PsychosisPEPsy-IdentityNCT06464848
Narrative Identity and Its Relationship to Subjective Multidimensional Well-being in First Episode Psychosis
An observational study of Psychosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The transition between adolescence and adulthood (generally defined as ages 18 to 25) is a key developmental window for narrative identity and psychotic disorders. Narrative identity is positively associated with mental health. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosis
- What is being tested?
- Narrative identity task
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of three study groups: 1. Patients with a first psychotic episode (FEP group) 2. Controls, representative of the general French population (control group) 3. Patients with a diagnosis of psychotic or bipolar disorder ("chronic" group). All three groups will be matched for age, sex and socio-educational level.
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient managed in the psychiatry department (consultation or hospitalization) for a FEP defined by :
- Presence of positive psychotic symptoms (delirium(s) and/or hallucination(s) and/or conceptual disorganization) for at least one week, either every day or at least 3 times a week for at least one hour.
- Never having taken neuroleptic antipsychotic treatment (except antipsychotic treatment started for the current episode)
- Disorder meeting DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder lasting more than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder lasting more than 7 days, other specific or non-specific disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.
- Patient diagnosed with a disorder meeting DSM 5 criteria for more than 18 months from the following list: delusional disorder, brief psychotic disorder lasting more than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder lasting more than 7 days, other specific or non-specific disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.
Who cannot join
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject unable to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant or breastfeeding
- Patient with history of traumatic brain injury
Show all 10Show fewer
- Patient with moderate to severe mental retardation (IQ≤ 55)
- FEP related to a drug-induced psychotic disorder or due to another medical condition
- Participant with lifetime experience of FEP
- Participant with a diagnosis of a disorder meeting DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder lasting more than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder lasting more than 7 days, other specific or non-specific disorder of the schizophrenic spectrum or other psychotic disorder, bipolar I or II disorder with psychotic features congruent and not congruent with mood, substance-induced bipolar disorder with psychotic features congruent and not congruent with mood, major depressive disorder with psychotic features congruent and not congruent with mood.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Department of Psychiatry, Nimes University Hospital
Nîmes, Gard, 30029
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Julie Jourdan
About this study
The transition between adolescence and adulthood (generally defined as ages 18 to 25) is a key developmental window for narrative identity and psychotic disorders. Narrative identity is positively associated with mental health. This study will focus on the acquisition of narrative identity in First Episode Psychosis (FEP) and its impact on multidimensional subjective well-being.
The study authors hypothesize that levels of the various components of narrative identity would be lower in the FEP group than in the "chronic" and control groups, and in the "chronic" group versus control group. Given the paucity contradictory nature of the published literature, no hypotheses have been formulated regarding these correlations and predictions. Instead, this study will remain an exploratory analysis in the different samples.
- Conditions
- Psychosis
- Being tested
- Narrative identity task
- Keywords
- First episode psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative identity taskOther
All participants will be asked to develop five personal narratives in response to different types of questions: trauma, transgression, negative memory, self-definition, and turning point. For each story, participants will be asked to provide details of where they were, who they were with, what happened and how they and others reacted, what happened, how they reacted and how others reacted (if at all).
| Study group | Role | What they receive |
|---|---|---|
| FEP | Participants recruited from PEPsy-CM trial Receives: Other: Narrative identity task | |
| Chronic | Participants recruited from psychiatric department of CHU de Nimes Receives: Other: Narrative identity task | |
| Controls | Recruited from social media and word of mouth Receives: Other: Narrative identity task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narrative identity between groups according to life history task
Narrative identity calculated from five narratives scored by the clinician considering agency, communion, redemption/contamination, affective tone, exploratory processing, growth, construction of meaning, elaboration of facts and interpretations, affective tone, ending valence, temporal/causal/thematic coherence and overall coherence.
Measured: Day 0
Secondary outcomes (18)
Multidimensional subjective well-being between groups
PERMA-Profiler score. A 15-item questionnaire measured on 11-item Likert scales. Higher scores indicate greater well-being. An overall well-being score is calculated by creating an average score for each item, and subscale scores are calculated by averaging the three items in each subscale
Measured: Day 0
Psychopathology symptoms between FEP and chronic groups
Positive and negative symptom scale (PANSS). The positive scale ranges from 7 to 49, the negative scale from 8 to 56, the hostility scale from 6 to 46, the disorganization scale from 5 to 35, and the anxiety scale from 4 to 28. The total score ranges from 30 to 210.
Measured: Day 0
Personal recovery between FEP and chronic groups
Stage of Recovery Instrument (STORI). Ten themes are evaluated, each comprising five items ranging from 0 "Not at all true" to 5 "Quite true", corresponding to the five stages of personal recovery. A score is calculated for each stage, ranging from 0 to 50, and the participant is assigned to the stage with the highest score.
Measured: Day 0
Personality between groups
10-item Big Five Inventory (BFI-10). The BFI-10 is a 10-item scale assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability and openness
Measured: Day 0
Childhood trauma between groups
Childhood Trauma Questionnaire (CTQ). The short version of the CTQ consists of 28 items, including a 3-item denial scale and five 5-item scales. The scale items are a Likert-type scale with five response options (from 1 = "never true" to 5 = "very often true")
Measured: Day 0
Patient functioning between groups
Global Assessment of Functioning (GAF). Scores range from 0-100, whereby lower scores represent lower functioning
Measured: Day 0
Anxiety and depression between groups
Hospital Anxiety and Depression Scale (HADS). A 14-item questionnaire of which 7 assess depression and 7 anxiety. The sum of the item scores for each subscale produces an anxiety score and/or a depression score
Measured: Day 0
Social and individual performance between groups
Personal and Social Performance scale (PSP). Higher scores correspond to better personal and social functioning, scores from 91 to 100 correspond to more than adequate functioning, while scores below 30 correspond to such poor functioning that intensive supervision is required
Measured: Day 0
General quality of life between groups
World Health Organization Quality Of Life Brief (WHOQOL-BREF). The WHOQOL-bref has four types of five-point response scales, allowing assessment of intensity (Not at all-Extremely), ability (Not at all-Completely), frequency (Never-Always) and evaluation (Very dissatisfied/Very bad-Very satisfied/Very good), which vary according to the items
Measured: Day 0
Autobiographical memory function between groups
Thinking About Life Experiences scale (TALE-15). This self-questionnaire consists of two general questions, followed by 15 items specific to autobiographical memory functions, each consisting of 5 items. The response items are associated with a 5-point Likert scale ranging from "Almost never" to "Very frequently".
Measured: Day 0
Insight between FEP and chronic groups
Birchwood Insight Scale (BIS). The questionnaire measures multidimensional assessment of insight, comprising 8 questions (3-point Likert scale: "agree", "disagree" or "unsure"). The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
Measured: Day 0
Health-related quality of life between groups
EuroQol-5Dimension (EQ-5D-5L) questionnaire. This questionnaire comprises five items representing the 5 dimensions of quality of life and a 0-100 visual analog scale. The answers are combined into a 5-digit number describing the patient's health status e.g., health status "11111" indicates the absence of problems
Measured: Day 0
Depression between groups
Beck Depression Inventory (BDI-11).
Measured: Day 0
Medical adherence between FEP and chronic groups
Medication Adherence Rating Scale (MARS). The 10 items assess behaviors, attitudes and treatment experience. Scores range from 0 to 10
Measured: Day 0
Patient-perceived improvement in clinical condition between FEP and chronic groups
Clinical Global Impression (CGI). The questionnaire comprises two measures: Severity and Improvement, both measured on a scale of 1 to 7
Measured: Day 0
Verbal fluency between groups
Participants must list as many words as possible beginning with the letter "P", belonging to the semantic category "animals".
Measured: Day 0
Word recall and recognition between groups
California Verbal Learning Test (CVLT-11). Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall). The word list is presented as a shopping list.
Measured: Day 0
Non-verbal reasoning between groups
Matrices test taken from the Wechsler Adult Intelligence Scale to measure non-verbal reasoning abilities, general visual intelligence and perceptual organization skills.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Jourdan, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464848
- Sponsor's protocol ID
- LOCAL/2023/JJ-03
- Acronym
- PEPsy-Identity
- Status last verified
- Aug 2025
- First submitted
- 13 Jun 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Identity and Its Relationship to Subjective Multidimensional Well-being in First Episode Psychosis
- ClinicalTrials.gov ID
- NCT06464848
- Acronym / sponsor ID
- PEPsy-Identity / LOCAL/2023/JJ-03
- Conditions
- Psychosis
- Keywords
- First episode psychosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The transition between adolescence and adulthood (generally defined as ages 18 to 25) is a key developmental window for narrative identity and psychotic disorders. Narrative identity is positively associated with mental health. This study will focus on the acquisition of narrative identity in First Episode Psychosis (FEP) and its impact on multidimensional subjective well-being.
The study authors hypothesize that levels of the various components of narrative identity would be lower in the FEP group than in the "chronic" and control groups, and in the "chronic" group versus control group. Given the paucity contradictory nature of the published literature, no hypotheses have been formulated regarding these correlations and predictions. Instead, this study will remain an exploratory analysis in the different samples.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FEP | – | Other: Narrative identity taskParticipants recruited from PEPsy-CM trial |
| Chronic | – | Other: Narrative identity taskParticipants recruited from psychiatric department of CHU de Nimes |
| Controls | – | Other: Narrative identity taskRecruited from social media and word of mouth |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of three study groups: 1. Patients with a first psychotic episode (FEP group) 2. Controls, representative of the general French population (control group) 3. Patients with a diagnosis of psychotic or bipolar disorder ("chronic" group). All three groups will be matched for age, sex and socio-educational level.
Key inclusion criteria (7 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient managed in the psychiatry department (consultation or hospitalization) for a FEP defined by :
- Presence of positive psychotic symptoms (delirium(s) and/or hallucination(s) and/or conceptual disorganization) for at least one week, either every day or at least 3 times a week for at least one hour.
- Never having taken neuroleptic antipsychotic treatment (except antipsychotic treatment started for the current episode)
Key exclusion criteria (10 listed)
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject unable to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative identity taskAll participants will be asked to develop five personal narratives in response to different types of questions: trauma, transgression, negative memory, self-definition, and turning point. For each story, participants will be asked to provide details of where they were, who they were with, what happened and how they and others reacted, what happened, how they reacted and how others reacted (if at all). | Other | Chronic, Controls, FEP |
Primary outcome
Narrative identity between groups according to life history task
Time frame: Day 0
Narrative identity calculated from five narratives scored by the clinician considering agency, communion, redemption/contamination, affective tone, exploratory processing, growth, construction of meaning, elaboration of facts and interpretations, affective tone, ending valence, temporal/causal/thematic coherence and overall coherence.
18 secondary outcomes
Multidimensional subjective well-being between groups
Time frame: Day 0
Psychopathology symptoms between FEP and chronic groups
Time frame: Day 0
Personal recovery between FEP and chronic groups
Time frame: Day 0
Personality between groups
Time frame: Day 0
Childhood trauma between groups
Time frame: Day 0
Patient functioning between groups
Time frame: Day 0
Anxiety and depression between groups
Time frame: Day 0
Social and individual performance between groups
Time frame: Day 0
General quality of life between groups
Time frame: Day 0
Autobiographical memory function between groups
Time frame: Day 0
Insight between FEP and chronic groups
Time frame: Day 0
Health-related quality of life between groups
Time frame: Day 0
Depression between groups
Time frame: Day 0
Medical adherence between FEP and chronic groups
Time frame: Day 0
Patient-perceived improvement in clinical condition between FEP and chronic groups
Time frame: Day 0
Verbal fluency between groups
Time frame: Day 0
Word recall and recognition between groups
Time frame: Day 0
Non-verbal reasoning between groups
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Jourdan principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Jourdan (04.66.68.34.26, julie.jourdan@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narrative identity between groups according to life history task (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.